Orange Book product · Generic (ANDA)
NIKKI
DROSPIRENONE; ETHINYL ESTRADIOL
At a glance
May 27, 2014
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 27, 2014
12 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
DROSPIRENONE; ETHINYL ESTRADIOL
Strength
3MG;0.02MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 201661
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DROSPIRENONE; ETHINYL ESTRADIOL
- 2006YAZBrand (NDA)
NDA 021676 · BAYER HLTHCARE
- 2001YASMINBrand (NDA)
NDA 021098 · BAYER HLTHCARE
- 2020DROSPIRENONE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 213034 · HETERO LABS
- 2019KYRAGeneric (ANDA)
ANDA 202318 · SUN PHARM
- 2019DROSPIRENONE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 211944 · HETERO LABS
- 2019KEMEYAGeneric (ANDA)
ANDA 202138 · SUN PHARM
- 2018DROSPIRENONE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 210017 · JUBILANT CADISTA
- 2018ZUMANDIMINEGeneric (ANDA)
ANDA 209407 · AUROBINDO PHARMA LTD
- 2018LO-ZUMANDIMINEGeneric (ANDA)
ANDA 209632 · AUROBINDO PHARMA LTD
- 2017DROSPIRENONE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 209423 · JUBILANT CADISTA
- 2017DROSPIRENONE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 203291 · PHARMOBEDIENT
- 2016DROSPIRENONE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 207245 · NAARI PTE
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
